Medical Device Classification (Class I–IV) in Japan: Overview and How to Determine a Device's Class

In Japan, medical devices are classified into four classes (I–IV) according to the degree of risk they pose to the human body if a malfunction occurs, and the pharmaceutical-affairs procedure required for each class (notification, certification, or approval) differs accordingly. The type of marketing-business licence that must be obtained is also linked to the class. This page first gives an at-a-glance table of the definition, regulation, marketing-business licence, and typical examples for Class I to IV, then walks through each class, the exception for Software as a Medical Device (SaMD), where classification sits within the overall confirmation flow, and where to consult (the PMDA) when you cannot determine it yourself.

In product development, the basic order is to first confirm whether your product falls under the definition of a medical device, next identify its generic name (JMDN), and then confirm its classification from there. That said, until the generic name is fixed, the classification often cannot be fixed either. Because classification follows a defined set of rules, however, you can still form a rough estimate even before the generic name is settled. Ultimately, consult the PMDA to confirm.

A note for overseas readers: English-language information on Japan's medical device regulations is limited, and most communication with the regulatory authorities and Japanese companies is conducted in Japanese. Please use this page as a reference for your own understanding, and conduct actual inquiries to the regulatory authorities through a Japanese partner such as a DMAH (Designated Marketing Authorization Holder).

Contents

1. Basics of Classification (PMD Act and the GHTF Rules)

Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the PMD Act), medical devices are classified into four classes according to the degree of risk they pose to the human body in the event of a malfunction. Japan's medical device classification follows the classification rules of the GHTF (Global Harmonization Task Force).

The higher the class, the higher the risk to the human body is considered to be, and the required pharmaceutical-affairs procedure (notification → certification → approval) becomes correspondingly stricter. Japan's approach to classification is set out in a notification that builds on the GHTF rules.

The classification rules for highly controlled medical devices, controlled medical devices, and general medical devices are set out in Appendix 1 of the (Director-General's) notification, based on the classification rules discussed by the Global Harmonization Task Force (GHTF).

【Original】高度管理医療機器、管理医療機器及び一般医療機器に係るクラス分類のルールについては、医療機器規制国際整合化会議（GHTF）において議論されているクラス分類ルールを基本に、（局長通知）の別紙１において示しているところである。

Source: 「高度管理医療機器、管理医療機器及び一般医療機器に係るクラス分類ルールの改正について」 (Revision of the Classification Rules for Highly Controlled, Controlled, and General Medical Devices; Yakushokuhatsu 0510 No. 8), Director-General of the Pharmaceutical and Food Safety Bureau, MHLW, 10 May 2013. https://www.pmda.go.jp/files/000242914.pdf (Japanese)

2. Classification, Regulation, and Marketing-Business Licence at a Glance

The relationship among Class I–IV, the categories under the PMD Act, the pre-market procedure, and the marketing-business licence is summarized in the table below. The three procedures are referred to in Japanese as notification ("Todokede"), certification ("Ninsho"), and approval ("Shonin"); certification is carried out by a Registered Certification Body (RCB, "Ninshokikan").

Class Category under the PMD Act Level of risk Pre-market procedure Marketing-business licence required Typical examples
Class I General medical devices Extremely low Notification to the PMDA Third-class or higher Scalpels, tweezers, stethoscopes, adhesive bandages, gauze
Class II Controlled medical devices Relatively low Certification by a Registered Certification Body (ministerial approval where no certification standard exists) Second-class or higher MRI systems, ultrasound diagnostic systems, electronic thermometers, electronic blood-pressure monitors, injection needles, hearing aids
Class III Highly controlled medical devices Relatively high Ministerial approval (third-party certification also possible where a certification standard exists) First-class Ventilators, dialyzers, artificial joints, vascular catheters, contact lenses
Class IV Highly controlled medical devices Extremely high (may directly endanger life) Ministerial approval (most rigorous review) First-class Pacemakers, implantable cardioverter-defibrillators, artificial heart valves, coronary stents

Source:

The medical-device marketing-business licence is divided into first-class, second-class, and third-class according to the class of device handled. A first-class licence covers all of Class I–IV, a second-class licence covers Class I and II, and a third-class licence covers Class I only. The "marketing-business licence required" column above therefore shows the minimum licence needed to handle a product of that class.

Second-class: may market only Class I (general) and Class II (controlled) medical devices. Third-class: may market only Class I (general) medical devices.

【Original】第二種…クラスⅠ（一般医療機器）とクラスⅡ（管理医療機器）のみを製造販売できる。第三種…クラスⅠ（一般医療機器）のみ製造販売できる。

Source: 「医療機器製造業登録・製造販売業許可が必要な範囲と取得方法について」 (Scope and Method of Acquisition of Medical Device Manufacturing Registration and Marketing-Business Licences), 京都府健康福祉部薜務課（京都府薜事支援センター） https://www.ki21.jp/kobo/r3/kyomed/kyoto_iryoukiki_panfu.pdf (Japanese)

Note that the authority granting the marketing-business licence is the governor of each prefecture, and the application is filed with the pharmaceutical affairs division of the prefecture where the office is located. This is a different filing destination from the product-by-product approval / certification / notification (handled by the PMDA or a Registered Certification Body).

For overseas companies: when appointing a Japanese MAH, confirm that it holds a licence class matching the highest device class you intend to market in Japan.

3. Class I: General Medical Devices

  • Definition: Devices considered to pose an extremely low risk to the human body even if a malfunction occurs.
  • Regulation: A marketing notification ("Todokede") to the PMDA is required. Approval or certification is not required.
  • Typical examples:
    • Surgical instruments: scalpels, tweezers, forceps, scissors
    • Diagnostic tools: stethoscopes, tongue depressors
    • Sanitary materials: adhesive bandages, gauze
    • Others: X-ray film, many dental laboratory instruments

4. Class II: Controlled Medical Devices

  • Definition: Devices considered to pose a relatively low risk to the human body if a malfunction occurs.
  • Regulation: Certification ("Ninsho") by a third-party certification body registered under the law is required (some items require approval).
  • Typical examples:
    • Diagnostic imaging systems: MRI systems, ultrasound diagnostic systems, CT scanners
    • Biological information monitors: electronic thermometers, electronic blood-pressure monitors, electrocardiographs
    • Treatment instruments: catheters for digestive organs, injection needles
    • Others: home-use massage devices, hearing aids, electronic endoscopes

5. Class III: Highly Controlled Medical Devices

  • Definition: Devices considered to pose a relatively high risk to the human body, requiring appropriate control because a malfunction could have a serious effect on life or health.
  • Regulation: Marketing approval ("Shonin") by the Minister of Health, Labour and Welfare is required. The application may require the submission of data on the results of clinical trials.
  • However, Class III devices for which a certification standard has been established may instead undergo certification ("Ninsho") by a Registered Certification Body. Being Class III does not necessarily mean the device requires ministerial approval.
  • Typical examples:
    • Life-support and function-substituting devices: ventilators, dialyzers, infusion pumps
    • Implant products: artificial bones, artificial joints, dental implants
    • Treatment instruments: vascular catheters, laser surgical devices
    • Others: contact lenses in long-term contact with blood or tissue

Since 25 November 2014, Class III highly controlled medical devices for which a certification standard exists have become eligible for certification by a third-party certification body.

【Original】なお、2014年11月25日より、クラスIIIの高度管理医療機器のうち、認証基準のあるものについては、第三者認証機関による認証が可能となりました。

Source: 「医療機器」 (Medical Devices — relationship between medical device marketing and device classification), PMDA https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/devices/0028.html (Japanese)

6. Class IV: Highly Controlled Medical Devices

  • Definition: Devices that are highly invasive to the patient and considered to pose an extremely high risk to the human body, requiring particularly careful control because a side effect or functional failure could directly endanger life.
  • Regulation: As with Class III, marketing approval ("Shonin") by the Minister of Health, Labour and Welfare is required. The approval review is the most rigorous.
  • Typical examples:
    • Cardiac and vascular implants: pacemakers, implantable cardioverter-defibrillators, artificial heart valves, coronary stents
    • Brain and nervous-system devices: deep brain stimulation devices
    • Others: heart-lung machines, products using biologically derived raw materials

Note: Both Class III and Class IV are categorized as "highly controlled medical devices."

7. Classification of Software as a Medical Device (SaMD)

For Software as a Medical Device (SaMD), classification is likewise determined according to the GHTF classification rules described above. However, software equivalent to a general medical device (Class I) is excluded from the scope of medical devices. Therefore, even functionality that would be subject to notification as Class I if it were a tangible product does not fall under the definition of a medical device when it is software, and is outside the scope of regulation under the PMD Act. Note that the Class I row of the table above does not apply to Software as a Medical Device.

As stated in item 3 above, software equivalent to a general medical device (Class I medical device) is excluded from the scope of medical devices.

【Original】なお、上記3に記載のとおり、一般医療機器(クラスⅠ医療機器)に相当するプログラムは、医療機器の範囲から除かれる。

Source: 「プログラムの医療機器該当性に関するガイドラインの一部改正について」 (Partial Revision of the Guideline on the Medical Device Applicability of Software/Programs; Yakuseikishinhatsu 0331 No. 1 / Yakuseikanmahatsu 0331 No. 4), MHLW, 31 March 2023. https://www.mhlw.go.jp/content/11120000/001082227.pdf (Japanese)

Being outside the scope of regulation does not mean that anything may be claimed about the software. For software that is not a medical device (including software equivalent to Class I), the same guideline states that, to prevent user misunderstanding, it is advisable to indicate that the software is not intended for use in the diagnosis, treatment, or prevention of disease, or that it is not a medical device. The approach to the level of risk of Software as a Medical Device is organized in the following document, which supplements the classification rules notification.

Source: 「プログラムの医療機器該当性に関するガイドライン」 (Guideline on the Medical Device Applicability of Software/Programs), Pharmaceutical Safety and Environmental Health Bureau, MHLW, 31 March 2021 (partially revised 31 March 2023), "6: Approach to the Level of Risk Affecting Human Life and Health." https://www.pmda.go.jp/files/000240233.pdf (Japanese)

For an overview of Japan's SaMD framework in English, see PMDA, "Software as a Medical Device (SaMD)." https://www.pmda.go.jp/english/review-services/reviews/0009.html (English)

8. How to Estimate a Device's Class

Classification is not defined product by product, but by generic name (JMDN, Japan Medical Device Nomenclature, "Ippantekimeisho"). Therefore, the shortest route to learning your product's class is to first identify the applicable generic name.

  1. Organize the product's intended use, principle of operation, and whether it is invasive.
  2. Look for similar existing products and check their generic name.
  3. Check the classification linked to that generic name.
  4. If there is no applicable generic name, form a rough estimate using the GHTF classification rules (Appendix 1 of Yakushokuhatsu 0510 No. 8).

For new medical devices with no existing generic name, there may be no similar product, so the classification is unknown. In such cases, referring to the classification rules described above gives a rough estimate. Ultimately, the PMDA decides the classification during the review process.

9. Where to Consult When You Need to Confirm the Classification (PMDA)

Once you have worked through the steps above and still cannot determine the classification with confidence, consult the PMDA. Prepare a product overview first, then apply for the free General Consultation.

Note that PMDA consultations are conducted in Japanese. While it is possible to attend with an interpreter, we recommend confirming the classification through a Japanese partner well-versed in regulatory affairs, such as a (D)MAH or a regulatory-affairs consultant.

If you would like to check in English where to direct your inquiry—although classification itself is unlikely to be determined through these channels—the following English-language consultation routes may help.

10. Reference Materials

Reference materials in English

Reference materials in Japanese

11. Related JPRO Pages

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